Site Qualifications Questionnaire

CleveloxTM (clevidipine) Study
Sponsored by The Medicines Company

Please complete all fields and click submit when completed.   Thank you!

Date:               mm/dd/yyyy
RESEARCH PROJECT
In which of the following protocols would your site be interested in participating?
  ESCAPE - Pre-Op   ECLIPSE - SNP
  ESCAPE - Post-Op   ECLIPSE - NICARDIPINE
  ECLIPSE - NTG   To be determined
INVESTIGATOR
Hospital/Clinic Name:
Investigator First Name:
Investigator Last Name:
Address:
City:
State:
Zip Code:
Telephone:   xxx-xxx-xxxx
Fax:   xxx-xxx-xxxx
Email:
Discipline of Investigator:
(e.g. anesthesiology, cardiac surgery)
STUDY COORDINATOR
Does Clinical Site have a designated Study Coordinator?
  Yes      No
Coordinator First Name:
Coordinator Last Name:
INVESTIGATIONAL EXPERIENCE
1.      Are you conducting or planning to conduct other investigational study(ies) during the time period - November, 2003 through September, 2004 - that might be in conflict with enrollment for this study?
  Yes      No          If yes, how many other investigations (estimate)?    
2. How many coordinators and sub-investigators will participate in the study?
Study Coordinator
Sub-Investigator(s)
Other
3. How many years of experience do you and your sub-investigators have in conducting clinical studies in this patient population?
Principal Investigator
Study Coordinator
Sub-Investigator(s)
Other
4. Do you have experience with electronic CRF?     Yes      No
5. Type of cardiac surgery treated at clinical site (check all that apply):
Approx. Number of
Cases per Year
  CABG
   OPCAB
   MidCAB
   Valve Repair
   Valve Replacement
  Other (fill in below)  
     
     
6. How many times per week do you perform a second case on the same day?   
7. Which antihypertensive agents are used at your institution to manage perioperative hypertension?   (check all that apply)
  Nitroglycerin   Enalaprilat
  Sodium nitroprusside   Atenolol
  Nicardipine   Diltiazem
  Esmolol   Anesthetic agent
  Other     
8. Which methods will you use to identify the patients for this study?
  Scheduled Procedures
  Other, please explain:     
INSTITUTIONAL REVIEW BOARD / ETHICS COMMITTEE
9. Does clinical site have a local IRB/IEC? If yes, please fill out information below:
  Yes      No
10. Name of Local IRB/IEC:
11. First Name of Local IRB/IEC Chairperson:
12. Last Name of Local IRB/IEC Chairperson:
13. Address:
14. City:
15. State:
16. Zip Code:
17. Telephone:   xxx-xxx-xxxx
18. Fax:   xxx-xxx-xxxx
19. Email:
20. How frequently does the IRB meet?
21. Please provide the next two submission dates: 
             mm/dd/yyyy
22. Can site use another IRB/IEC (e.g. Central/Western IRB)?
  Yes      No
CONTRACTS
Who is responsible for review and approval of study contracts and budget?
23. First Name :
24. Last Name :
25. Phone:   xxx-xxx-xxxx
STUDY DRUG
26. Does your facility have an "on-site" pharmacy?
  Yes      No
27. Will a research pharmacist be available for dispensing of study drug?
  Yes      No
28. Will the pharmacy have a sufficient storage space for refrigerated study drug kits?
  Yes      No
* Please provide the name and address of the pharmacist/pharmacy where the study drug will be shipped:
29. Pharmacy Name:
30. Pharmacist First Name:
31. Pharmacist Last Name:
32. Address:
33. City:
34. State:
35. Zip Code:
FACILITY
36. Do you have internet access required for electronic data capture (EDC)?
  Yes      No          If yes, please select high speed or dial up:  
37. Do you have access to the free-dial/touch tone telephone lines to use IVRS (Interactive Voice Response System)?
  Yes      No
38. Do you have an on-site bio-clinical lab facility?
  Yes      No
39. Are CK-MBs routinely analyzed?
  Yes      No
40. Please provide the names of BP monitors that are used at your facility:
Operating Room (OR)
Manufacturer:
Model:
Intensive Care Unit (ICU)
Manufacturer:
Model:
COMMENTS
Comments:

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